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FDA 510(k)

P.S.M. SURGICAL HOOD

K-Number: K761070 · 1976-12-30

ApplicantThe Owenby Co.
Decision Date1976-12-30
Product CodeFXY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

P.S.M. SURGICAL HOOD is the device name listed in this FDA 510(k) record. The listed applicant is The Owenby Co.. It received FDA 510(k) clearance on 1976-12-30 under 510(k) number K761070. The device is classified under product code FXY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.S.M. SURGICAL HOOD?

P.S.M. SURGICAL HOOD is a medical device that received FDA 510(k) clearance on 1976-12-30. The listed applicant is The Owenby Co.. The 510(k) number is K761070.

When did P.S.M. SURGICAL HOOD receive FDA 510(k) clearance?

P.S.M. SURGICAL HOOD received FDA 510(k) clearance on 1976-12-30, under 510(k) number K761070.

Who is the listed applicant for P.S.M. SURGICAL HOOD?

The FDA 510(k) record lists The Owenby Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P.S.M. SURGICAL HOOD?

The FDA product code for P.S.M. SURGICAL HOOD is FXY.

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Other records listing The Owenby Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K801628RESTRAINT, PROTECTIVEK801627COVER, LIMBK801626ARM SLINGK801532STOCKINETTE, STERILE TWO PLY W/PULL TABSK801531ARM SLINGK790210STOCKINETTE, TUBULAR UNBLEACHED

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Related Devices (Code: FXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222214ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)Thi Total Healthcare Innovation GmbHK200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverStryker CorporationK904969HOOD, OPERATING, SURGICALChicago Assoc. For Retarded CitizensK904276DISPOSABLE BEARD COVERAnago, Inc.K903533STERI-SHIELDBiomedical Devices, Inc.K902677STERI-SHIELDBiomedical Devices, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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